|- candidate number||16211|
|- NTR Number||NTR4381|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jan-2014|
|- Secondary IDs||45897 |
|- Public Title||The Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial|
|- Scientific Title||The Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial|
|- hypothesis||Vitamin D supplementation reduces the incidence of delayed union in fracture patients with a vitamin D insufficiency, compared to placebo.|
|- Healt Condition(s) or Problem(s) studied||Vitamin D, Vitamin D deficiency, Vitamin D suppletion , Delayed union, Fracture |
|- Inclusion criteria||- Age between 18 and 50 years
- Extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture)|
|- Exclusion criteria||- Refracture; pathologic fracture; complicated fracture; Injury severity Score > 16; pregnancy
- Growth hormone deficiency; Immune compromised, sarco´dosis
- Use of: Vitamin D, corticosteroids, digoxin, calcium / bisfosfonate, phenobarbital, phenyto´n
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-jan-2017|
|- Target number of participants||250|
|- Interventions||Group studie medication:
25.000IU Colecalciferol once a month during a period of 4 months.
Placebo once a month during a period of 4 months.
|- Primary outcome||Delayed union, defined as incomplete consolidation (clinically and radiologically) after 4 months. |
|- Secondary outcome||- Non-union, defined as absent fracture consolidation after 9 months
- Complications during fracture healing (infection, mal-Union, refracture, (re)operation).
- Perceived pain
- Functional recovery
- Quality of life
|- Timepoints||1, 4, 8, 12, 16, 26 and 52 weeks after fracture.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. I.B. Schipper|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. I.B. Schipper|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||Background:
A large part of the population has a relative or absolute vitamin D deficiency. Recent, as yet unpublished results show that 70% of the patient population between 18 and 50 years with a fracture has a vitamin D insufficiency (25 (OH) D <75 nmol / L), and 40% has a deficiency (25 (OH) D <50 nmol / L). Vitamin D plays a role in the cellular process of fracture healing. However, the number of available clinical studies on the role of vitamin D on fracture healing is scarce and these studies mainly focus on elderly fracture patients. The clinical effect of vitamin D status and vitamin D supplementation on fracture healing is unknown in the fracture population aged between 18 and 50 years.
The influence of the initial vitamin D status and the effect of vitamin D supplementation on the fracture consolidation will be studied. An evidence-based recommendation to vitamin D status and vitamin D supplementation in fracture treatment will be based on the study results. Primarily, the effect of vitamin D supplementation on bone healing, the incidence of delayed fracture healing (delayed union) will be investigated in a vitamin D insufficient fracture population. Secondary the effect of vitamin D supplementation on the occurrence of complications , functional outcome, and health-related quality of life will be investigated. We will also examine the influence of the initial vitamin D status on the fracture healing, and conduct a cost-effectiveness analysis on vitamin D supplementation.
In this double-blind randomized controlled trial, patients are randomized between 25.000IU Colecalciferol once a month for 4 months and placebo once a month for 4 months. Patients will be seen according to a fixed schedule during which fracture healing will be monitored using radiography, and blood samples will be obtained for determination of the vitamin D status.
250 patients aged between 18 and 50 years, with an extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture).|
|- Main changes (audit trail)|
|- RECORD||26-jan-2014 - 31-mrt-2014|